| Outcome Measures: |
Primary: Atorvastatin PK parameters: AUC(0-tlast), Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration, Part B and optional Part D: up to Day 34|Atorvastatin PK parameters: AUC(0-inf), Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Part B and optional Part D: up to Day 34|Atorvastatin PK parameters: Cmax, Maximum observed plasma concentration, Part B and optional Part D: up to Day 34|Rosuvastatin PK parameters: AUC(0-tlast), Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration, Part A and optional Part C: up to Day 11|Rosuvastatin PK parameters: AUC(0-inf), Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Part A and optional Part C: up to Day 11|Rosuvastatin PK parameters: Cmax, Maximum observed plasma concentration, Part A and optional Part C: up to Day 11|Digoxin PK parameters: AUC(0-tlast), Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration, Part A and optional Part C: up to Day 11|Digoxin PK parameters: AUC(0-inf), Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Part A and optional Part C: up to Day 11|Digoxin PK parameters: Cmax, Maximum observed plasma concentration, Part A and optional Part C: up to Day 11|Midazolam PK parameters: AUC(0-tlast), Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration, Part B and optional Part D: up to Day 34|Midazolam PK parameters: AUC(0-inf), Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Part B and optional Part D: up to Day 34|Midazolam PK parameters: Cmax, Maximum observed plasma concentration, Part B and optional Part D: up to Day 34 | Secondary: ECC5004 Safety parameters: Number of participants with adverse events (AEs), Safety Assessment evaluated through adverse events, Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40|ECC5004 Safety parameters: Number of participants with vital sign abnormalities, Safety Assessment evaluated through vital signs, Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40|ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, Safety Assessment evaluated through electrocardiograms (ECGs), Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40|ECC5004 Safety parameters: Number of participants with physical examination abnormalities, Safety Assessment evaluated through physical examination, Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40|ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities, Safety Assessment evaluated through clinical laboratory assessments, Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40|Atorvastatin safety parameters: Number of participants with adverse events (AEs), Safety Assessment evaluated through adverse events, Part B and optional Part D: up to Day 40|Atorvastatin safety parameters: Number of participants with vital sign abnormalities, Safety Assessment evaluated through vital signs, Part B and optional Part D: up to Day 40|Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG), Safety Assessment evaluated through electrocardiograms (ECGs), Part B and optional Part D: up to Day 40|Atorvastatin safety parameters: Number of participants with physical examination abnormalities, Safety Assessment evaluated through physical examination, Part B and optional Part D: up to Day 40|Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities, Safety Assessment evaluated through clinical laboratory assessments, Part B and optional Part D: up to Day 40|Rosuvastatin safety parameters: Number of participants with adverse events (AEs), Safety Assessment evaluated through adverse events, Part A and optional Part C: up to Day 16|Rosuvastatin safety parameters: Number of participants with vital sign abnormalities, Safety Assessment evaluated through vital signs, Part A and optional Part C: up to Day 16|Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, Safety Assessment evaluated through electrocardiograms (ECGs), Part A and optional Part C: up to Day 16|Rosuvastatin safety parameters: Number of participants with physical examination abnormalities, Safety Assessment evaluated through physical examination, Part A and optional Part C: up to Day 16|Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities, Safety Assessment evaluated through clinical laboratory assessments, Part A and optional Part C: up to Day 16|Digoxin safety parameters: Number of participants with adverse events (AEs), Safety Assessment evaluated through adverse events, Part A and optional Part C: up to Day 16|Digoxin safety parameters: Number of participants with vital sign abnormalities, Safety Assessment evaluated through vital signs, Part A and optional Part C: up to Day 16|Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, Safety Assessment evaluated through electrocardiograms (ECGs), Part A and optional Part C: up to Day 16|Digoxin safety parameters: Number of participants with physical examination abnormalities, Safety Assessment evaluated through physical examination, Part A and optional Part C: up to Day 16|Digoxin safety parameters: Number of participants with clinical laboratory abnormalities, Safety Assessment evaluated through clinical laboratory assessments, Part A and optional Part C: up to Day 16|Midazolam safety parameters: Number of participants with adverse events (AEs), Safety Assessment evaluated through adverse events, Part B and optional Part D: up to Day 40|Midazolam safety parameters: Number of participants with vital sign abnormalities, Safety Assessment evaluated through vital signs, Part B and optional Part D: up to Day 40|Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, Safety Assessment evaluated through electrocardiograms (ECGs), Part B and optional Part D: up to Day 40|Midazolam safety parameters: Number of participants with physical examination abnormalities, Safety Assessment evaluated through physical examination, Part B and optional Part D: up to Day 40|Midazolam safety parameters: Number of participants with clinical laboratory abnormalities, Safety Assessment evaluated through clinical laboratory assessments, Part B and optional Part D: up to Day 40|ECC5004 PK parameters: AUC (0-τ), Area under the Plasma Concentration-Time Curve during the Dosing Interval, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34|ECC5004 PK parameters: AUC(0-24), Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34|ECC5004 PK parameters: tmax, Time of the maximum observed plasma concentration, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34|ECC5004 PK parameters: t1/2, Apparent terminal elimination half-life, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34|ECC5004 PK parameters: CL/F, Apparent Clearance, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34|ECC5004 PK parameters: Ctau, Observed Concentration at the End of the Dosing Interval, Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
|
